Perjeta pertuzumab regulatory update

FDA provided new details about the approval of Perjeta pertuzumab and revealed that the agency's manufacturing and product quality staff had recommended withholding approval of a BLA for the breast cancer drug until Genentech resolved manufacturing problems discovered in March. Earlier this month, FDA approved only Perjeta that contains drug substance produced during 2010 that was unaffected by the recent problems (see BioCentury, June 11).

According to an agency review document, the staff had expressed concern that Genentech has yet to demonstrate a consistent process that would ensure continued supply of commercial material. FDA generally requires validation of a manufacturing process to be completed before approval. However, the agency said Perjeta's 6.1 month improvement in progression-free survival (PFS) in the Phase III CLEOPATRA study "suggests a meaningful clinical benefit" and outweighs the risk of a future disruption of drug supply (see BioCentury, Dec. 12, 2011). Details on the specific manufacturing issues and the amount of Perjeta produced in 2010 were redacted from the document. Genentech referred to the manufacturing issue as a "cell growth issue," but declined to elaborate. The company did say it expects to meet demand for the drug. ...